Prescription drug · NDA
Retin-A (Tretinoin) NDC 0187-5172
Tretinoin .1 mg/g · Gel · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5172-15 | 0018751721500187517215 | 1 TUBE in 1 CARTON (0187-5172-15) / 15 g in 1 TUBEMarketed from Jul 30, 1979 | |
| 0187-5172-45 | 0018751724500187517245 | 1 TUBE in 1 CARTON (0187-5172-45) / 45 g in 1 TUBEMarketed from Jul 30, 1979 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Retin-A
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bausch Health US, LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017955
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0187-5172_18a7b6d8-e3c4-676f-e063-6294a90a0498SPL ID 18a7b6d8-e3c4-676f-e063-6294a90a0498SPL set ID 9556d73d-c573-4e0a-9feb-764ce2d1107bRxCUI 106302, 106303, 198300, 208328, 208330, 208331, 208334, 313450, 313451, 701305UNII 5688UTC01RUPC 0301875170455, 0301875172459
- Pharmacologic class
- Retinoid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400187517215followed by a unit qualifier and the quantityPackage 00187-5172-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Excerpt only. Read the full label for complete information.
About NDC 0187-5172
- What is NDC 0187-5172?
- 0187-5172 is the product NDC for Retin-A (tretinoin), Tretinoin .1 mg/g gel, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Retin-A (Tretinoin).
- What is the active ingredient?
- Tretinoin.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Retin-A?
- 4 other product NDCs are listed under this name. See all Retin-A NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Retin-A products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Retin-Atretinoin | Tretinoin .25 mg/g | CreamTopical | Bausch Health US, LLC | 0187-5160 | 00187-5160-2000187-5160-45 |
| Retin-Atretinoin | Tretinoin .25 mg/g | GelTopical | Bausch Health US, LLC | 0187-5170 | 00187-5170-1500187-5170-45 |
| Retin-Atretinoin | Tretinoin .5 mg/g | CreamTopical | Bausch Health US, LLC | 0187-5162 | 00187-5162-2000187-5162-45 |
| Retin-Atretinoin | Tretinoin 1 mg/g | CreamTopical | Bausch Health US, LLC | 0187-5164 | 00187-5164-2000187-5164-45 |
Other NDCs under NDA 017955
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tretinoin | Tretinoin .1 mg/g | GelTopical | Mylan Pharmaceuticals Inc. | 0378-8085 |
| Tretinoin | Tretinoin .1 mg/g | GelTopical | Bryant Ranch Prepack | 71335-2952 |